Back to resultsBrain Stimulation and Meditation for Pain After Total Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
active tDCS paired with active MBM
sham tDCS paired with sham MBM
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria: elective unilateral knee total replacement mentally capable of reading, giving consent and following instructions being able to answer questions in English not pregnant Exclusion Criteria: history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia alcohol/substance abuse current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists hospitalization within the preceding year for psychiatric illness no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Sites / Locations
- Tallahassee Orthopedic ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
preoperative active tDCS+MBI
preoperative sham tDCS+MBI
Arm Description
Active tDCS with simultaneous meditation intervention will be applied.
Sham tDCS with simultaneous sham MBM intervention will be delivered.
Outcomes
Primary Outcome Measures
Analgesic consumption
The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.
Secondary Outcome Measures
numerical rating scale (NRS)
The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Brief Pain Inventory (BPI)
It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being "does not interfere" (0) and "completely interferes" (10). A total interference score can also be calculated by taking the sum of all the items.
Patient Health Questionnaire-4 (PHQ-4)
with regards to emotional function, considering established relations between pain, anxiety, and depression, measures of anxiety and depression will be taken
Pain Catastrophizing Scale (PCS)
to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4).
Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Change in descending pain modulation (CPM) as measured by the quantitative sensory testing
Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion.
Full Information
NCT ID
NCT05673720
First Posted
December 19, 2022
Last Updated
February 10, 2023
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT05673720
Brief Title
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
Official Title
Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current stimulation and mindfulness for pain after total knee arthroplasty
Detailed Description
The project is to assess the preliminary feasibility, acceptability, and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) undergoing TKR. And to determine the effects of 5, 20-minute preoperative self-administered tDCS sessions combined with brief MBI on analgesic medication consumption following TKR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
preoperative active tDCS+MBI
Arm Type
Experimental
Arm Description
Active tDCS with simultaneous meditation intervention will be applied.
Arm Title
preoperative sham tDCS+MBI
Arm Type
Sham Comparator
Arm Description
Sham tDCS with simultaneous sham MBM intervention will be delivered.
Intervention Type
Device
Intervention Name(s)
active tDCS paired with active MBM
Intervention Description
Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session for 5 times via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session for 5 times by a recorded meditation.
Intervention Type
Device
Intervention Name(s)
sham tDCS paired with sham MBM
Intervention Description
For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
The dose of every opioid received within 3 days postoperatively will be transcribed and converted into standardized parenteral morphine equivalents using the Centers for Disease and Control Prevention Guidelines on opioids. A total in milligrams will be calculated for each day and means will be obtained for all groups.
Time Frame
day 3 after surgery
Secondary Outcome Measure Information:
Title
numerical rating scale (NRS)
Description
The NRS total score ranges from 0 (no pain) to 100 (most intense pain imaginable).
Time Frame
day 3 after surgery
Title
Brief Pain Inventory (BPI)
Description
It includes seven items and evaluates the impact of pain on general activity, mood, walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item represents a subscale and can be scored and analyzed individually (0-10), with the anchors being "does not interfere" (0) and "completely interferes" (10). A total interference score can also be calculated by taking the sum of all the items.
Time Frame
day 3 after surgery
Title
Patient Health Questionnaire-4 (PHQ-4)
Description
with regards to emotional function, considering established relations between pain, anxiety, and depression, measures of anxiety and depression will be taken
Time Frame
day 3 after surgery
Title
Pain Catastrophizing Scale (PCS)
Description
to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items), and helplessness (6 items). Each item is rated on a 5-point scale with the end points not at all (score=0) and all the time (score=4).
Time Frame
day 3 after surgery
Title
Change in pain related cortical response using a continuous wave, multichannel Functional near-infrared spectroscopy (fNIRS) imaging system
Description
Pain-related cortical response will be measured using a continuous-wave, multichannel fNIRS imaging system (LIGHTNIRS, Shimadzu, Kyoto, Japan) with three semiconductor lasers at 780, 805, and 830 nm. Optical recordings will be collected during thermal pain stimulation.
Time Frame
change from baseline at day 5 of intervention
Title
Change in descending pain modulation (CPM) as measured by the quantitative sensory testing
Description
Descending pain modulation will be determined by the change in pressure pain threshold on the trapezius immediately after the immersion of the contralateral hand up to the wrist in a cold water bath at 12°C for one minute, with higher CPM scores indicating better descending pain modulation. Descending pain modulation will be reflected by an increase in pressure pain threshold after cold water immersion.
Time Frame
change from baseline at day 5 of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective unilateral knee total replacement
mentally capable of reading, giving consent and following instructions
being able to answer questions in English
not pregnant
Exclusion Criteria:
history of brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation
systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia
alcohol/substance abuse
current use of sodium channel blockers, calcium channel blockers and NMDS receptor antagonists
hospitalization within the preceding year for psychiatric illness
no access to a device with internet access that can be used for secure videoconferencing for real-time remote supervision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geraldine Martorella, PhD
Phone
850-644-6028
Email
gmartorella@fsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lindsey Park
Phone
850-644-6012
Email
lpark2@fsu.edu
Facility Information:
Facility Name
Tallahassee Orthopedic Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phillip Worts, PhD
12. IPD Sharing Statement
Learn more about this trial
Brain Stimulation and Meditation for Pain After Total Knee Arthroplasty
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